# K033020: Impak Acrylic Repair Resin Liquid

- Pathway: 510(k) (Traditional)
- Applicant: Cmp Industries, LLC
- Decided: Dec 19, 2003 after 84 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Apr 28, 2016 · Class II · Z-2097-2016: Possible presence of foreign material (rust).
- Apr 28, 2016 · Class II · Z-2098-2016: Possible presence of foreign material (rust).
- Mar 2, 2016 · Class II · Z-2089-2016: Possible presence of foreign material (rust).
- Nov 18, 2013 · Class II · Z-1089-2016: During the current inspection of CMP Industries, the FDA Investigator discovered that the firm had conducted a recall of Impak Acrylic Liquid Batch 103113 in 2013 due to potential rust without notifyi

## Indications for use
CMP IMPAK denture relining, repairing/rebasing liquid resin is indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base.

Source page: https://510kreport.com/device/K033020
Methodology: https://510kreport.com/methodology